Integrity Applications, Inc. (Exact Name of Registrant as Specified in Its Charter)

Transcription

1 Date of Report (Date of earliest event reported): October 29, 2013 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C Registrant s telephone number, including area code: 972 (8) FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Integrity Applications, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware (State or Other Jurisdiction (Commission (IRS Employer of Incorporation) File Number) Identification No.) 102 Ha Avoda Street, P.O. Box 432, Ashkelon, Israel L (Address of Principal Executive Offices) (Zip Code) N/A (Former Name or Former Address, if Changed Since Last Report) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: o Written communications pursuant to Rule 425 under the Securities Act (17 CFR ) o o o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR a-12) Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR d-2(b)) Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR e-4(c))

2 Item Regulation FD Disclosure. On October 29, 2013, Avner Gal, the Chief Executive Officer of Integrity Applications, Inc., a Delaware corporation (the Company ), will present on behalf of the Company at the AMIZINO Fall 2013 Small Cap/Micro Cap Investment Conference in Seattle, Washington (the AMIZINO Conference ). A copy of the presentation to be presented by Mr. Gal on behalf of the Company at the AMIZINO Conference is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference in this Item The information contained in this Item 7.01, including Exhibit 99.1, shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act ), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing by the Company under the Exchange Act or the Securities Act of 1933, as amended. ITEM Financial Statements and Exhibits. (d) Exhibits. Exhibit Number Description 99.1 Presentation to be presented by Avner Gal at the AMIZINO Conference

3 Signatures Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Date: October 29, 2013 INTEGRITY APPLICATIONS, INC. By: /s/ Avner Gal Name: Avner Gal Title: Chief Executive Officer

4 EXHIBIT INDEX Exhibit Number Description 99.1 Presentation to be presented by Avner Gal at the AMIZINO Conference

5 Exhibit 99.1 Your track to health!... (OTCQB: IGAP) AMIZINO Fall 2013 Small Cap / Micro Cap Investment Conference Seattle, WA Avner Gal President & CEO October 29,

6 Disclaimer This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and various provisions of the U.S. Securities Act of 1933, as amended, and the U.S. Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, included in this presentation are forward-looking statements. Forward-looking statements included in this presentation address, among other things, our future product development activities, strategies and timing of seeking regulatory approval to market our current product candidate. These statements are based on certain historical trends, current conditions and expected future developments as well as other factors the Company believes are appropriate in the circumstances. In addition to statements which explicitly describe these risks and uncertainties, readers are urged to consider statements labeled with the terms expects, anticipates and other similar words and phrases to be uncertain and forward-looking. All of the forward-looking statements made in this presentation are qualified by these cautionary statements and there can be no assurance that the actual results anticipated by the Company will be realized or, even if substantially realized, that they will have the expected consequences to or effects on the Company or its business or operations. Whether actual results will conform to the Company s expectations and predictions is subject to a number of risks and uncertainties that may cause actual results to differ materially. See the risks described in our reports filed with the Securities and Exchange Commission, including under the heading "Risk Factors" of our Annual Report on Form 10-K for the year ended December 31,

7 About Integrity Applications (OTCQB: IGAP) Developing a family of noninvasive glucose monitors for diabetics, to measure their blood glucose level without the pain of drawing blood, and without incremental cost per measurement R&D began in 2001 (Israel); Initial prototype completed in late 2003; Methodology patent received October 2005; Incorporated in Delaware in 2010; 3

8 GlucoTrack Model DF-F Main Unit (MU) Personal Ear Clip (PEC) 4

9 GlucoTrack Unique Approach Three independent (non-optical) technologies Attempts (by others) to develop non-invasive glucose monitors have mostly been based upon optical technologies, and have not been successful Patented combination of technologies (simultaneously): ü Ultrasound ü Electromagnetic (Conductivity) ü Thermal (Heat Capacity) ü Unique algorithms Infrequent re-calibrations (*), by simple process Current model, DF-F: Spot measurement device 5

10 GlucoTrack Features & Benefits Easy to operate; User friendly (Just clip it! ) Clear and simple instructions Color touch screen Large digits and Audible result within a minute History graph and list of past 1000 readings Average glucose level calculated displayed Glucose average within desired points of time Calculated HbA1c level (estimated) Easy to download data to external storage device Main Unit supports up to 3 users (individually calibrated) Measurement alerts (pre-set by users) 6

11 Like an ipod! (Prof. Steven Edelman) Just Clip it! 7

12 GlucoTrack Results 36 T1DM; 240 T2DM Body Mass Index (BMI): 33.1+/ Kg/m2 Age: / years Clinical trials, conducted by third party, covered virtually the entire demography, including skin colors and levels of education. CEG Zone Data Points Percent A 4,309 46% B 4,730 51% C 180 2% D 135 1% E 5 0% Total 100% 97% of the results fall into the clinically acceptable A&B zones of the Clarke Error Grid (CEG). GlucoTrack model DF-F has CE Mark approval 8

13 Prevalence of Diabetes: Years Old Source: IDF Diabetes Atlas, 5 th Edition,

14 Prevalence of Diabetes: Years Old (ctnd.) 10

15 Advances in Blood Glucose Monitoring Meter interprets more accurately the light reflected by a color on the meter into a readable number FDA, CDC and ADA discuss SMBG: key tool in diabetes treatment First continuous glucose monitoring via a device implanted under the skin is released A strip of paper changes its color according to the patient s glucose level Glucometer (Bayer) becomes the first home glucose monitoring device Study shows that patients who conduct SMBG reduce chances for complications (76% for eye disease, 50% for kidney disease and 60% for nerve disease) Industry begins to produce lower-cost home glucose meters, allowing better access to more patients Cygnus introduces GlucoWatch. Causes skin irritation, thus cannot be called noninvasive 11

16 Advances in Blood Glucose Monitoring June 2013 GlucoTrack model DF-F, a truly non-invasive glucose monitor, has gained CE Mark approval 12

17 Importance of SMBG is Recognized! 13

18 HbA1c as a Function of SMBG HbA1c as a function of SMBG measurements per day (Source: Diabetes Atlas, 2 nd edition, 2003) ADA (June 2012): Reducing HbA1c a Little Less than 1 Point Reduces CV Risk by 45% 14

19 Yet Significant Barriers Exist Prick the fingertip (ouch ) Draw blood, infuse drop onto a test strip Painful; Expensive 15

20 Compelling Economics Assumptions: Invasive measurement costs $1.00 each; Retail price for GlucoTrack DF-F: $2,000 (including one PEC); PEC costs $100; replaced every 6 months; Excludes re-calibration costs, which are expected to be approximately $70, in total, over a five year period. 16

21 Survey results: T1DM & T2DM 17

22 Market volume Source: Kalorama Information Diabetes and Diabetic Complications March 2007 Self Monitoring of Blood Glucose Market was estimated as $8B In 2010 Source: Pharmalive.com, May

23 Recent Achievements; Anticipated Actions Improving the device ü Smaller version of Personal Ear Clip (PEC) - enables use by people with smaller ear lobes (awaiting clinical trials); ü PMCF: collecting data to enable algorithms improvement; ü Embedding state of the art Anti-cloning & Encryption (H/W& S/W) (implementation); ü Using new connector to increase reliability of the PEC (Done); ü Multi-lingual device (Hebrew; English; Russian; Arabic; French). 19

24 Recent Achievements; Anticipated Actions Preparation for mass production manufacturing ü Audited potential manufacturers (Israel, China, Taiwan, Philippines); ü Finalization of Main Unit (MU) mold (E/O December); ü Design & build tools & testers for MU (E/O December); ü Finalization of PEC mold (E/O November); ü Improving assembling process of PEC sensors (E/O December); ü Development of Self Test Aid (STA) (E/O November); ü Functional testers & tools for PEC electrical & mechanical parts (E/O December). 20

25 Recent Achievements; Anticipated Actions Marketing & Sales Activities ü Booth in EASD Conference (September); ü Table in Medica, Dusseldorf, Germany (November); ü On going participation in conferences (posters; presentations); ü Launched a redesigned website (October); ü Meetings with Key Opinion Leaders in selected markets; ü Discussions re: Distribution agreements (Europe; Middle East; Asia; South East Asia; South America); ü Training Field Engineers. 21

26 Recent Achievements; Anticipated Actions Regulatory & Other Activities ü Clinical pilot in South Africa (November); ü Clinical trials for minors, 6-18 years old (E/O Q1/14); ü Submission of 6 months trial s results (Approval expected E/O Feb.); ü Preparation for FDA clinical pathway (with NAMSA); ü Development of DF-B Model (for developing countries); ü Development of Web application (uploading data; analysis; links to distributors websites; sales capabilities); ü IP enhancing (patents applications); ü Study regulatory pathways and requirements: China CFDA; Taiwan TFDA; other countries; Discussions; Workshops. 22

27 Products Road Map DF-B: Basic model for use in developing countries DF-C: Continuous monitoring of glucose level DF-N: Provides Night time advanced warning of hypoglycemic episodes DF-D: Warns Drivers of low glucose level DF-I: System for pediatric Incubators DF-P: Device for (IGT) Pre-diabetic patients 23

28 Competitive Landscape # Company Product Technology Calibration Measurement Picture Comments 1 Echo Therapeutics (MA, USA) Symphony Ultra Sound (ISF) 12 hours between calibrations Continuous For ICU; In clinical trials 2 Grove Instruments (MA, USA) Gi-200 Optical Bridge No data Spot In clinical trials 3 Cnoga Medical (Israel) TensorTip CGM - Combo Optical; Bioparameters; Look-up table Long process Many (>200) points Spot CE Mark Approved; Selling 4 Freedom Meditech (CA, USA) I Sugar X Optical (in front of the eye) No data Spot Diagnostics Convert to monitoring 5 AiMedics (Australia) HypoMon Skin Bio-sensors No data Continuous Received CE -Mark; Like DF-N 6 Cybiocare Optical (Quebec, Canada) OHD Optical No data Continuous Like DF-N 24

29 Management Avner Gal: President & CEO, Chairman (Co-Founder) Retired Naval Commander, strong Engineering & Management background David Malka: Executive VP & COO (Co-Founder) Rich experience in Operations, including founding Operation Departments Kobi Bar-Shalom: CFO Rich experience in different size private & public companies Eugene Naidis: Project Manager Rich experience in Research & Development projects Avner Avrahami: QA Manager Long term experience in QA activities 25

30 Medical Advisory Board Dr. Ilana Harman-Bohem, MD Manager of Diabetic department at Soroka University Medical Center Prof. Yariv Malimovka, MD Senior consultant to Spanish medical centers in blood vessels & surgery Adi Ickowicz / MedicSense (Regulatory affairs) Rich experience in medical devices arena (FDA & CE Mark) Adi Gluzberg / MedicSense (Regulatory affairs) Rich experience in medical devices arena (FDA & CE Mark) 26

31 Capitalization Approximately 5.14 million shares of common stock outstanding (October 7, 2013); Approximately 472,000 shares of the Company s common stock are issuable upon exercise of outstanding stock options; Approximately 1.57 million shares of common stock are issuable upon exercise of outstanding warrants; Approximately 1.48 million shares of common stock are issuable upon conversion of outstanding shares of convertible preferred stock. 27

32 Your track to health!... Thank You! 28